McClellan Outlines Priorities at Healthcare Services Conference

Originally Published MX March/April 2003

BUSINESS NEWS

Erik Swain

Hailing the medical device user fee act as a key means for FDA to satisfy its regulatory responsibilities, Commissioner Mark B. McClellan, MD, PhD, recently assured an industry audience that reducing review times for new product submissions will continue to be an agency priority.

Speaking earlier this month at the UBS Warburg Global Healthcare Services Conference, in New York City, McClellan said that although the tasks facing FDA have never been more complex, "there have never been better opportunities to meet those challenges." McClellan's speech delineated key agency priorities for the near future.

Following through on its promise to reduce review times, said McClellan, the agency is asking industry to help determine why some product submissions must undergo more than one review cycle before they receive clearance or approval. In many cases, he said, it appears the initial application is missing something.